510(k) K182999

General Cutting Contra Handpiece by Nakanishi, Inc. — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2019
Date Received
October 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type